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General Classification of Health and Food Products

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In Singapore, medicinal and other health-related products are regulated under various legislations such as the Medicines Act, the Poisons Act, the Sale of Drugs Act, the Medicines (Advertisement and Sale) Act and the Misuse of Drug Regulations. The control of health products is under the purview of Health Sciences Authority (HSA). Products that are presently subjected to licensing requirements under HSA include Western medicinal products, Chinese proprietary medicines and Cosmetic products. On the other hand, food and supplements of food nature come under the purview of the Singapore Food Agency (SFA). The import and sale of these products in Singapore are governed by the Sale of Food Act and the Food Regulations. Importers of these products are required to ensure that the food products they intend to import comply with the requirements of the Food Regulations, including the labelling requirements. The classification of products in the food-health product interface is a challenging one as it is dependent on various factors. HSA and SFA have developed a classification tree* to assist companies determine the likely classification of their product. However, this tree serves only as a guide and companies are advised to seek confirmation with the respective Authority on the product’s classification. For detailed information on the regulation of health or food products in Singapore, you may visit the websites of the respective controlling agencies.

* Click for more details Classification Tree

Classification introduction Useful Links

The following classification tree provides guidance in the classification of products whose presentation, ingredients or function fall into the food-health product interface.

Classification Tree for Products in the Food-Health Product Interface

TAKEN AS PART OF A DAILY DIET * SUPPLEMENTATION TO A TAKEN FOR MEDICINAL (Including Chinese Medicinal Material commonly used in Food) # DIET * PURPOSE *

(Purified extracts / isolated substances)

Conventional Pharmaceutical E.g. capsules, tablets, Food Presentation * softgels, pills, etc Presentation *

Ad libitum (No Defined E.g. drink defined dosage) dosages beverages, grains, loose No defined doses Small unit dose powders, No limits to amount consumed Daily doses snack bars, No defined duration. Appropriate restrictions noodles etc No restriction to age-groups and warnings on usage

Please check with SFA * Please check with HSA *

Please note that the above serves only as a guide. It may be updated from time-to-time. You may contact the respective Agencies* for clarification if you are unsure of the classification of your product.

* Click for more details #: A Chinese medicinal material (CMM) is a medicinal material (, animal part or ) used in the practice of traditional Chinese Medicines Part of a Daily Diet

Back to Classification Tree Definition Examples of food substances

Definition of “Part of a Daily Diet” The product or substances of food nature that provide the nutrients (such as carbohydrates, protein, dietary fibre, and minerals) which contributes to a normal healthy diet. The product or substance may be used as part of a meal or taken to replace a meal.

 Examples of substances that can be taken as part of a diet:

1. Bee pollen 10. Honeysuckle immature (Flos Lonicerae, 金银花) 2. Bird nest 11. Jew's ear / Black fungus (Auricularia, 木耳) 3. Chinese woodfrog / Hashima (Rana Siccus, 雪蛤 / 哈士蟆) 12. Jujube (Semen Ziziphi Spinosae, 酸枣仁) 4. Chlorella 13. Lily bulb (Bulbus Lilii, 百合) 5. Chrysanthemum flower (Flos Chrysanthemi, 菊花) 14. Noni (Morinda citrifolia) 6. Fermented soybean (Semen Sojae Preparatum, 淡豆豉) 15. Perilla leaf, fruit (Perilla frutescens, 紫苏叶/子) 7. (Rhizoma Zingiberis Recens / Rhizoma Zingiberis, 16. Spirulina 生姜 / 干姜) 17. Star fruit (Fructus Anisi Stellati, 八角茴香) 8. seed (Semen Ginkgo, 白果) 18. Tangerine peel (Pericarpium Citri Reticulatae, 陈皮) 9. Grosvenor momordica fruit (Fructus Momordicae, 罗汉果) 19. Wolfberry fruit (Fructus Lycii, 枸杞)

 Examples of products that can be taken as part of a diet:

1. Energy food 6. Meal replacement 2. Essence of Chicken / duck / fish / deer 7. essence 3. Granules for making soup e.g. Bah Kut , 8. Protein and carbohydrate-based supplements 4. and drinks for general, regular consumption e.g. 9. (tea bags or granules), 夏桑菊 (Xia sang ju), 白 10. Sports supplements 花蛇舌草 (Bai hua she she cao) 11. Wine or vinegar drink containing herbal ingredients 5. Herbal jelly e.g. 龟苓膏 (Gui ling gao) commonly used in food

Back to Classification Tree Supplementation to a Diet

Back to Classification Tree Definition Examples of supplemental substances

Definition of “Supplementation to a Diet” This product or substance is taken to provide additional nutrients which cannot be obtained or is not adequately obtained through normal dietary means.

This product or substance is taken for nutritional or functional benefits by providing nutrients in amounts above those normally obtained from the diet or by providing nutrients which are not normally present in conventional food substances. The nutrients are taken for health maintenance, particularly for specific nutrient deficiencies or in times of stress when normal dietary intake is insufficient to address the additional nutrient need.

 Examples of substances that can be taken as a supplement of a diet: 1. Alpha 23. Inositol hexaniacinate 2. Alpha-linoleic acid 24. Inositol hexaphosphate 3. Amino acids e.g. Leucine, Lysine, Methionine, , Histidine, 25. Isoflavones L-, , , , 26. 4. Bee propolis 27. Methylsulphonylmethane 5. Bioflavanoids 28. Milk thistle (Silybum marianum) 6. Black cohosh (Cimicifuga racemosa) 29. Omega-3 or Omega-6 oils e.g. Eicopentaenoic acid (EPA), 7. Brindle (Garcinia cambogia) Docosahexaenoic acid (DHA) 8. Bulk laxatives e.g. Psyllium (Plantago), Ispahugula 30. Pycnogenol 9. Cat’s claw ( tomentosa) 31. 10. Chitosan 32. Phosphatidylserine 11. Chondroitin 33. sterols including phytosterols, and beta- 12. (E. purpurea, E. augustifolia, E. pallida) sitosterol 13. Enzyme isolates e.g. Bromelain, papain 34. Prebiotics including fructo-oligosaccharides 14. Evening primrose oil 35. (In non-milk based products) including 15. Flaxseed (Linum usitatissimum) oil , Streptococcus thermophilus, Bifidobacteria 16. Garlic (Allium sativum) extracts e.g. oils, allicin, alliin 36. Protein isolates including whey protein isolates, 17. Ginger (Zingiber officinalis) extracts e.g. oils 37. Resveratrol 18. Ginseng products other than the tea form i.e. extracts (liquid or 38. Saw palmetto ( repens) granules), capsule and tablet 39. Senna (Cassia senna, C. acutifolia) 19. 40. St. John’s wort () 20. Green tea extracts e.g. 41. Soyabean isolates 21. (Paullina cupana) extracts 42. Starflower (Borage officinalis) seed oil 22. Herbal or floral teas with documented health functions e.g. 43. Tea tree extract Rooibos tea, tea, SOD tea e.g. 二十四味凉茶 44. White () 45. Wild yam extracts Back to Classification Tree Taken for Medicinal Purpose

Back to Classification Tree Definition Examples of medicinal substances

Definition of “Taken for a Medicinal Purpose” This product or substance is taken for medicinal purpose e.g. treating, preventing or diagnosing disease; or carries medicinal claim.

 Examples of substances that can be taken for a medicinal purpose:

1. Bael fruit (Aeglo marmelos) 10. Magnolia (, 五味子) 2. Baikal skullcap (Scutellaria baicalensis, 黄芩) 11. Olibanum (Boswellia carterii, 乳香) 3. Black cumin (Nigella sativa) 12. Omum (Ptychotis ajowan) 4. Brahmi (Bacopa monnieri) 13. Sandalwood (Santalum album) 5. Crowdipper (Pinellia ternata, 半夏) 14. Siler root (Saposhnikovia divaricata, 防风) 6. Doubleteeth pubescent angelica root (Angelica pubescens, 独活) 15. Huperzine A 7. Dyer’s woad root (Isatis tinctoria, 板蓝根) 16. Synthetic 8. Gambir vine (, 钩藤) 17. Charcoal 9. Gypsum Fibrosum (石膏) 18. K

 Examples of products that can be taken for a medicinal purpose:

1. Chinese Proprietary Medicines 2. Traditional Indian Medicines (e.g. , Siddha, Unani) 3. Traditional Malay Medicines (e.g. Jamu) 4. Western Pharmaceutical Drugs (e.g. Huperzine A, Synthetic Caffeine)

Back to Classification Tree Definitions

Back to Classification Tree Conventional Presentation Pharmaceutical Presentation

Presentation The presentation of a product refers to its external appearance. Generally, food products would be presented in conventional food presentation and health products in the pharmaceutical presentation.

Conventional Food Presentation Refers to the presentation of products in the conventional food format, including drink beverages, grains, loose powders, snack bars, noodles, soups, jelly, cereals, spreads, dairies, granules, drops etc and any other presentations as may be allowed by the Singapore Food Agency.

Pharmaceutical Presentation Refers to products that are presented in the pharmaceutical presentation, including tablets, capsules, caplets, softgels, gelcaps and any other pharmaceutical presentations as may be allowed by the Health Sciences Authority.

Back to Classification Tree Useful Links

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Websites related to regulation of Websites related to regulation of health products in Singapore food products in Singapore

HSA Website * . SFA Website *

. Health Products Regulation *

* Click for more details